Betamethasone Dipropionate Global Patent Coverage & Expiry Overview

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It is formulated by 17 pharmaceutical companies such as CHARTWELL RX, PADAGIS ISRAEL, LEO PHARMA AS and others. It is marketed under 7 brand names, including CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, ENSTILAR, CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE and others. Available in 4 different strengths, such as 0.064%;0.005%, EQ 0.05% BASE;1%, EQ 0.05% BASE/SPRAY and others, and administered through 8 routes including OINTMENT;TOPICAL, AEROSOL, FOAM;TOPICAL, CREAM;TOPICAL and others.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

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US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength Route of Administration Companies Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

Patent Number Publication Date Legal Status Patent Expiry Date
{"application_id":"55442","ingredient":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","trade_name":"WYNZORA","family_id":"483f188d180c4016b368","publication_number":"US10265265B2","cleaned_patent_number":"10265265","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-09-27","publication_date":"2019-04-23","legal_status":"Granted"} US10265265B2 Formulation 23 Apr, 2019 Granted 27 Sep, 2027
{"application_id":"54721","ingredient":"BETAMETHASONE DIPROPIONATE","trade_name":"SERNIVO","family_id":"14b6959345fc44e3b23e","publication_number":"US10179137B2","cleaned_patent_number":"10179137","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-08-31","publication_date":"2019-01-15","legal_status":"Patented case"} US10179137B2 Formulation 15 Jan, 2019 Patented case 31 Aug, 2030
{"application_id":"54714","ingredient":"BETAMETHASONE DIPROPIONATE","trade_name":"SERNIVO","family_id":"14b6959345fc44e3b23e","publication_number":"US9364485B2","cleaned_patent_number":"9364485","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-08-31","publication_date":"2016-06-14","legal_status":"Granted"} US9364485B2 Formulation 14 Jun, 2016 Granted 31 Aug, 2030
{"application_id":"54715","ingredient":"BETAMETHASONE DIPROPIONATE","trade_name":"SERNIVO","family_id":"14b6959345fc44e3b23e","publication_number":"US9433630B1","cleaned_patent_number":"9433630","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-08-31","publication_date":"2016-09-06","legal_status":"Granted"} US9433630B2 Formulation 06 Sep, 2016 Granted 31 Aug, 2030
{"application_id":"54716","ingredient":"BETAMETHASONE DIPROPIONATE","trade_name":"SERNIVO","family_id":"14b6959345fc44e3b23e","publication_number":"US9439911B2","cleaned_patent_number":"9439911","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-08-31","publication_date":"2016-09-13","legal_status":"Granted"} US9439911B2 Formulation 13 Sep, 2016 Granted 31 Aug, 2030
{"application_id":"54717","ingredient":"BETAMETHASONE DIPROPIONATE","trade_name":"SERNIVO","family_id":"14b6959345fc44e3b23e","publication_number":"US9655907B2","cleaned_patent_number":"9655907","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-08-31","publication_date":"2017-05-23","legal_status":"Granted"} US9655907B2 Formulation 23 May, 2017 Granted 31 Aug, 2030
{"application_id":"54719","ingredient":"BETAMETHASONE DIPROPIONATE","trade_name":"SERNIVO","family_id":"14b6959345fc44e3b23e","publication_number":"US9877974B2","cleaned_patent_number":"9877974","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-08-31","publication_date":"2018-01-30","legal_status":"Granted"} US9877974B2 Formulation 30 Jan, 2018 Granted 31 Aug, 2030
{"application_id":"54718","ingredient":"BETAMETHASONE DIPROPIONATE","trade_name":"SERNIVO","family_id":"14b6959345fc44e3b23e","publication_number":"US9775851B1","cleaned_patent_number":"9775851","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-08-31","publication_date":"2017-10-03","legal_status":"Granted"} US9775851B2 Formulation 03 Oct, 2017 Granted 31 Aug, 2030
{"application_id":"42732","ingredient":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","trade_name":"ENSTILAR","family_id":"15cfcf6c609749cabd42","publication_number":"US9566286B2","cleaned_patent_number":"9566286","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-10","publication_date":"2017-02-14","legal_status":"Granted"} US9566286B2 Formulation 14 Feb, 2017 Granted 10 Jun, 2031
{"application_id":"42734","ingredient":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","trade_name":"ENSTILAR","family_id":"15cfcf6c609749cabd42","publication_number":"US10617698B2","cleaned_patent_number":"10617698","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-10","publication_date":"2020-04-14","legal_status":"Patented case"} US10617698B2 Formulation 14 Apr, 2020 Patented case 10 Jun, 2031
{"application_id":"42735","ingredient":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","trade_name":"ENSTILAR","family_id":"15cfcf6c609749cabd42","publication_number":"US10660908B2","cleaned_patent_number":"10660908","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-10","publication_date":"2020-05-26","legal_status":"Granted"} US10660908B2 Formulation 26 May, 2020 Granted 10 Jun, 2031
{"application_id":"42736","ingredient":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","trade_name":"ENSTILAR","family_id":"15cfcf6c609749cabd42","publication_number":"US10682364B2","cleaned_patent_number":"10682364","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-10","publication_date":"2020-06-16","legal_status":"Granted"} US10682364B2 Formulation 16 Jun, 2020 Granted 10 Jun, 2031
{"application_id":"42702","ingredient":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","trade_name":"ENSTILAR","family_id":"15cfcf6c609749cabd42","publication_number":"US10688108B2","cleaned_patent_number":"10688108","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-10","publication_date":"2020-06-23","legal_status":"Granted"} US10688108B2 23 Jun, 2020 Granted 10 Jun, 2031
{"application_id":"42737","ingredient":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","trade_name":"ENSTILAR","family_id":"15cfcf6c609749cabd42","publication_number":"US10716799B2","cleaned_patent_number":"10716799","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-10","publication_date":"2020-07-21","legal_status":"Granted"} US10716799B2 Formulation 21 Jul, 2020 Granted 10 Jun, 2031
{"application_id":"42733","ingredient":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","trade_name":"ENSTILAR","family_id":"15cfcf6c609749cabd42","publication_number":"US10130640B2","cleaned_patent_number":"10130640","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-12-10","publication_date":"2018-11-20","legal_status":"Patented case"} US10130640B2 20 Nov, 2018 Patented case 10 Dec, 2031
{"application_id":"42731","ingredient":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","trade_name":"ENSTILAR","family_id":"15cfcf6c609749cabd42","publication_number":"US9119781B2","cleaned_patent_number":"9119781","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-12-10","publication_date":"2015-09-01","legal_status":"Granted"} US9119781B2 01 Sep, 2015 Granted 10 Dec, 2031
{"application_id":"114973","ingredient":"BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE","trade_name":"WYNZORA","family_id":"98dd89c286c74a3db665","publication_number":"US11696919B2","cleaned_patent_number":"11696919","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-03-18","publication_date":"2023-07-11","legal_status":"Granted"} US11696919B2 Formulation 11 Jul, 2023 Granted 18 Mar, 2039

Recent Clinical Trials

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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.

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